Comparative Evaluation of the Effect on Blood Pressure of an Equivalent Content of Sodium in the Form of Bicarbonate of Sodium and in the Form of Sodium Chloride, on "Sensitive Sodium" Subjects

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Many large-scale epidemiological studies have established a link between the average consumption of table salt (sodium chloride) and blood pressure. In France a survey conducted in 2001 showed that the average consumption of salt is 9 to 10g per people / day, and health authorities considered it appropriate to reduce consumption about 20%, by limiting contributions of sodium in prepared foods, bread.

In terms of basic and clinical research, the biological effects of sodium chloride dietary intake, have been the subject of numerous studies for several decades. This work showed that all subjects do not react uniformly to sodium chloride flows, determining what the investigators call people "sodium-sensitive". For these people the sodium intake elevated blood pressure, much more marked than in subjects called "sodium-resistant."

"Sodium-sensitive" people represent 10 to 30% of the population. A marked over-representation of this phenotype was observed in patients with hypertension or a family history of hypertension.

In addition, studies conducted in animals and humans indicate that sodium intake has a different impact on biological parameters mentioned above, as is done in the form of chloride salt or bicarbonate of sodium.

Based on these factors, investigators developed a clinical trial protocol intended to highlight a possible differential effect in the biological effects of the same sodium intake (2.56 g / day) orally, depending on the nature salt.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand

Criteria

Inclusion Criteria:

• - Systolic Blood pressure between 130-160 mmHg and/or diastolic 90-100, not treated and/or family history of arterial high blood pressure (Father or Mother),

• Between 18 and 75 years old

• Asymptomatic on the cardiovascular plan,

• Absence of known heart disorder,

• Brachial Perimeter between 22 and 42 cms,

• Creatinine clearance in the standards dating less than 12 months, (glomerular filtration rate > 60 ml / mn / 1.73m²),

• Agreeing to drink some sparkling water during the periods of study,

• Effective method of birth control for women with childbearing potential

• Cooperation and understanding enough to conform to the study obligations

• Voluntary gives written informed consent to participate in the study

• Affiliated at system of French social security

• Inscription or acceptation of inscription in the national register of volunteers involved in trials.

Exclusion Criteria:

• -Treated by corticoids

• Treated by prohibited medications

• Pregnant or breastfeeding

• Treated by anti-hypertensive drug

• History of heart disease or ischemic heart disease

• Lack of sinus rhythm

• Renal insufficiency (glomerular filtration rate > 60 ml / mn / 1.73m ²)

• Uncontrolled hypertension (> 160 / 100mmHg)

• Incompatible comorbidity with the study

• BMI > 35 kg / m2

• Invalidating cognitive disorders

• Anxiety to use the device to measure blood pressure alone at home judged by the investigator

• Diabetes (Type I and II)

• Chronic alcoholism

• Sports judged as intense (more than 3 hours per week of intense sports),

• Participation in another clinical trial, located in exclusion period or received benefits > 4500 euros during 12 months before the beginning of trial,

• Cooperation and understanding that do not allow him to follow the trial,

• Patients with minor or under guardianship.